Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures

NCT00448539 | Terminated Phase 3 Results

• 2 other identifiers: E2080-A001-3022016-004950-14
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 27

Brief Summary

This was an open-label extension study in adolescent and adult (between 12 and 80 years old) participants who had completed their participation in Study E2080-A001-301. The main objective of this study was to evaluate the safety and efficacy of long-term administration of rufinamide for the control of epileptic seizures in participants who had refractory partial seizures despite treatment with a maximum of three approved antiepileptic drugs (AEDs).

Conditions

Refractory Partial Onset Seizures

Keywords

Refractory Partial Onset Seizures, epilepsy

Outcome Measures

Primary Outcomes (1)

• Percentage Change in Total Partial Seizure Frequency Per 28 Days Relative to the Baseline Phase

  Seizure data was collected via patient diaries. "OL" refers to "open-label."

  Baseline, Titration Phase (Days 1 to 18), Maintenance Phase

Study Arms (2)

Rufinamide (Rufinamide During Core Study)

EXPERIMENTAL

Drug: Rufinamide

Rufinamide (Placebo During Core Study)

EXPERIMENTAL

Drug: Rufinamide

Interventions

Rufinamide DRUG

Dose will be maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).

Also known as: E2080

Rufinamide (Placebo During Core Study); Rufinamide (Rufinamide During Core Study)

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patient willing to participate and written consent signed by patient or legal guardian provided prior to entering this study or undergoing any study procedures. In addition, if the patient is unable to provide written informed consent and it is provided by a legal guardian, assent of the patient (if the patient is able) must also be obtained.
• Female patients of non-childbearing potential by reason of surgery, radiation, or menopause (at least one year post onset); female patients of childbearing potential who are using at least two approved methods of contraception (such as an intrauterine device \[IUD\], implant, oral contraceptive, or barrier method plus spermicide). Use of a low-dose estrogen oral contraceptive alone will not be permitted. Female patients of childbearing potential must agree to continue to use two approved methods of contraception through the follow-up visit or for 30 days after their final dose of study medication, whichever is longer.
• Discontinuation from Study E2080-A001-301 for any reason, before the termination of the study.
• Evidence of non-compliance with study drug or ongoing AED dosing during Study E2080-A001-301.
• Evidence of clinically significant disease (cardiac, respiratory, gastrointestinal, hepatic (e.g., ALT \> 3x ULN), hematologic, renal, or psychiatric disease, etc.) that in the opinion of the Investigator could affect the patient's safety or trial conduct.
• Progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
• History of alcohol abuse in the past 2 years.
• History of suicide attempt within the previous 10 years.
• Multiple drug allergies (dematological, heatological or organ toxicity) or more than one severe drug reaction.
• Concomitant use of felbamate or vigabatrin.
• Pregnancy.
• Clinically significant ECG abnormality.
• All patients with a diagnosis of Congenital Short QT Syndrome. Patients with a family history of Congenital Short QT Syndrome may be excluded on the basis of the Investigator's clinical judgement.
• Presence of major active psychiatric disorder. Patients will be allowed who are taking a stable dose of selective serotonin reuptake inhibitor (SSRI) or mixed serotonin and norepinephrine uptake inhibitor antidepressant.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (27)

University of South Alabama Medical Center

Mobile, Alabama, 36693, United States

Location

Clinical Trials, Inc.

Little Rock, Arkansas, 72205, United States

Location

Bradenton Research Center

Bradenton, Florida, 34205, United States

Location

University of Florida, The Neuroscience Institute at Shands

Jacksonville, Florida, 32209, United States

Location

Pediatric Neurologists of Palm Beach

Loxahatchee Groves, Florida, 33470, United States

Location

Pediatric Neurosciences, PA

Orlando, Florida, 32835, United States

Location

Bay Medical Center

Panama City, Florida, 32405, United States

Location

Child Neurology Associates, PC

Atlanta, Georgia, 30342, United States

Location

Southern Illinois University Neurology and Pharmacology

Springfield, Illinois, 62794-9643, United States

Location

McFarland Clinic PC

Ames, Iowa, 50010-3014, United States

Location

John Hopkins Hospital, Dept. of Neurology

Baltimore, Maryland, 21287, United States

Location

Hattiesburg Clinic

Hattiesburg, Mississippi, 39401, United States

Location

Comprehensive Epilepsy Care Center for Children and Adults

Chesterfield, Missouri, 63017, United States

Location

Dartmouth Medical School Neuroscience Center

Lebanon, New Hampshire, 03756-0001, United States

Location

Five Towns Neuroscience Research

Cedarhurst, New York, 11516, United States

Location

New York University Medical Centre, Comprehensive Epilepsy Center

New York, New York, 10016, United States

Location

Weill Cornell Medical Center, Comprehensive Epilepsy Center

New York, New York, 10021, United States

Location

Asheville Neurology Specialists

Asheville, North Carolina, 28806, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Medical University of Ohio at Toledo - Dept. of Neurology

Toledo, Ohio, United States

Location

Hospital of The University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4204, United States

Location

University of Pennsylvania Medical Center-Department of Neurology

Philadelphia, Pennsylvania, 19104-4283, United States

Location

University of Tennessee Health Sciences Center, Dept. of Neurology

Memphis, Tennessee, 38105, United States

Location

Access Clinical Trials, Inc

Nashville, Tennessee, 37203, United States

Location

Neurological Clinic of Texas, P.A.

Dallas, Texas, 75230, United States

Location

Texas Tech University Health Sciences Center, Dept. of Neuropsychiatry

El Paso, Texas, 79905, United States

Location

Fletcher Allen Healthcare

Burlington, Vermont, 05401, United States

Location

MeSH Terms

Conditions

Epilepsy

Interventions

rufinamide

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Limitations and Caveats

This study was terminated early by the sponsor due to the discontinuation of clinical development for rufinamide.

Results Point of Contact

• Title: Eisai Medical Information
• Organization: Eisai Inc.

esi_medinfo@eisai.com

1 8882472378

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2007
• First Posted: March 19, 2007
• Study Start: March 15, 2007
• Primary Completion: May 14, 2010
• Study Completion: May 14, 2010
• Last Updated: November 22, 2019
• Results First Posted: December 10, 2012

Record last verified: 2019-11

Locations

US (27)